Trial Outcomes & Findings for Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity (NCT NCT02390531)
NCT ID: NCT02390531
Last Updated: 2022-11-03
Results Overview
Success is defined as improvement\* by the 4-day exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. \* For infants with plus disease, improvement by the 4-day post-injection exam is defined as plus disease no longer being present. For infants with type 1 ROP without plus disease (i.e., zone I, stage 3), improvement by the 4-day post-injection exam is defined as: (1) a significant reduction in severity and/or extent of extraretinal neovascularization, and, (2) if pre-plus was present pre-injection, reduction in the degree of abnormal vascular dilation and/or tortuosity. A dose will be considered effective if it successfully treats at least 80% of subjects.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
120 participants
Primary outcome timeframe
4 weeks post-injection
Results posted on
2022-11-03
Participant Flow
Original reported enrollment was 121, however upon further review 2 patient identifiers were found to be the same patient, incorrectly enrolled twice, bringing the correct count to 120.
Participant milestones
| Measure |
Bevacizumab (0.250 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.063 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
16
|
24
|
10
|
14
|
9
|
12
|
24
|
|
Overall Study
COMPLETED
|
11
|
14
|
24
|
9
|
13
|
9
|
10
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Bevacizumab (0.250 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.063 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
Bevacizumab (0.002 mg)
Dosage of injected Bevacizumab injected into study eye. When both eyes were treated, the fellow eye received the next higher dose than received by the study eye. More study eyes than fellow eyes were treated because some infants had type 1 ROP in one eye only.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
2
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
0
|
Baseline Characteristics
Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Baseline characteristics by cohort
| Measure |
Bevacizumab (0.25 mg)
n=11 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=12 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.002 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
Gestational age at enrollment
|
24.81 Weeks
STANDARD_DEVIATION 1.49 • n=99 Participants
|
25.21 Weeks
STANDARD_DEVIATION 2.22 • n=107 Participants
|
24.82 Weeks
STANDARD_DEVIATION 1.42 • n=206 Participants
|
24.73 Weeks
STANDARD_DEVIATION 1.12 • n=7 Participants
|
24.48 Weeks
STANDARD_DEVIATION 1.14 • n=31 Participants
|
24.63 Weeks
STANDARD_DEVIATION 1.48 • n=30 Participants
|
24.45 Weeks
STANDARD_DEVIATION 1.23 • n=3 Participants
|
25.14 Weeks
STANDARD_DEVIATION 2.02 • n=6 Participants
|
24.84 Weeks
STANDARD_DEVIATION 1.61 • n=114 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
10 Participants
n=6 Participants
|
49 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
9 Participants
n=3 Participants
|
14 Participants
n=6 Participants
|
71 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
15 Participants
n=6 Participants
|
65 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
19 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
17 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
5 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
|
Birth Weight
|
726.27 grams
STANDARD_DEVIATION 219.23 • n=99 Participants
|
801.31 grams
STANDARD_DEVIATION 514.35 • n=107 Participants
|
652.08 grams
STANDARD_DEVIATION 156.88 • n=206 Participants
|
680.60 grams
STANDARD_DEVIATION 167.17 • n=7 Participants
|
677.93 grams
STANDARD_DEVIATION 147.02 • n=31 Participants
|
539.44 grams
STANDARD_DEVIATION 133.19 • n=30 Participants
|
624.67 grams
STANDARD_DEVIATION 155.14 • n=3 Participants
|
722.00 grams
STANDARD_DEVIATION 357.65 • n=6 Participants
|
686.97 grams
STANDARD_DEVIATION 281.43 • n=114 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post-injectionPopulation: Seven infants were excluded (4 infants died prior to 4-week outcome examination; 1 failed, but it was not confirmed by second examiner; 1 was injected with the wrong dose in the study eye; and 1 had the fellow eye treated in the absence of type 1 ROP within one week of the study eye).
Success is defined as improvement\* by the 4-day exam and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection. \* For infants with plus disease, improvement by the 4-day post-injection exam is defined as plus disease no longer being present. For infants with type 1 ROP without plus disease (i.e., zone I, stage 3), improvement by the 4-day post-injection exam is defined as: (1) a significant reduction in severity and/or extent of extraretinal neovascularization, and, (2) if pre-plus was present pre-injection, reduction in the degree of abnormal vascular dilation and/or tortuosity. A dose will be considered effective if it successfully treats at least 80% of subjects.
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=113 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Successful Treatment of ROP
0.063 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
21 Participants
|
—
|
|
Number of Participants With Successful Treatment of ROP
0.016 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
13 Participants
|
—
|
|
Number of Participants With Successful Treatment of ROP
0.004 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
—
|
|
Number of Participants With Successful Treatment of ROP
0.250 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
11 Participants
|
—
|
|
Number of Participants With Successful Treatment of ROP
0.125 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
14 Participants
|
—
|
|
Number of Participants With Successful Treatment of ROP
0.031 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
—
|
|
Number of Participants With Successful Treatment of ROP
0.008 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
9 Participants
|
—
|
|
Number of Participants With Successful Treatment of ROP
0.002 mg Bevacizumab
|
—
|
—
|
—
|
—
|
—
|
—
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeks post-injectionPopulation: In this optional portion of the study, data is available for 66 infants.
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of vascular endothelial growth factor (VEGF) and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated.
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=8 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=5 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=4 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=5 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=9 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Distribution of VEGF Levels
Any increase in VEGF
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of VEGF Levels
Decrease in VEGF by 1% to <25%
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Distribution of VEGF Levels
Decrease in VEGF by 25% to <50%
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Distribution of VEGF Levels
Decrease in VEGF by greater than or equal to 50%
|
9 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4 weeks post-injectionPopulation: In this optional portion of the study, data is available for 61 infants.
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated.
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=13 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=6 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=8 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=6 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=4 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=5 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=9 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Distribution of VEGF Levels
Any increase in VEGF
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Distribution of VEGF Levels
Decrease in VEGF by 1% to <25%
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Distribution of VEGF Levels
Decrease in VEGF by 25% to <50%
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Distribution of VEGF Levels
Decrease in VEGF by greater than or equal to 50%
|
7 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 weeks post-injectionPopulation: Given the optional nature of this blood draw, outcomes were only collected for 56 infants. Given small sample size, we combined all dose levels and reported for those who were enrolled in this optional portion of the study.
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=19 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=8 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=9 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=11 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Distribution of Avastin Levels
|
292 ng/mL
Interval 111.0 to 379.0
|
167 ng/mL
Interval 98.0 to 274.0
|
79 ng/mL
Interval 66.0 to 95.0
|
—
|
—
|
—
|
364 ng/mL
Interval 264.0 to 424.0
|
231 ng/mL
Interval 167.0 to 324.0
|
SECONDARY outcome
Timeframe: 4 weeks post-injectionPopulation: Given the optional nature of the blood draw and loss to follow up, 4 week data was only collected for 49 infants. Given small sample size, we combined all dose levels and reported for those who were enrolled in this optional portion of the study. Reporting the results overall matches the published MS.
The parents of each infant enrolled in the study will be given the option to participate in a study to measure levels of VEGF and Avastin in the plasma. Participants in this optional study will have blood collected for analysis The distribution of VEGF and Avastin levels (median, range, and quartiles) will be described before injection, and at 2 weeks and 4 weeks post-injection. For each dosage level, at 2, and 4-weeks post-injection, the change from pre-injection will be calculated, and a 95% confidence interval calculated for the change.
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=15 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=6 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=8 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=9 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=11 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Distribution of Avastin Levels
|
254 ng/mL
Interval 254.0 to 427.0
|
115 ng/mL
Interval 81.0 to 275.0
|
67 ng/mL
Interval 54.0 to 99.0
|
—
|
—
|
—
|
281 ng/mL
Interval 242.0 to 401.0
|
196 ng/mL
Interval 118.0 to 258.0
|
SECONDARY outcome
Timeframe: 12-month corrected agePopulation: Eyes, Seven enrolled study eyes and 11 enrolled fellow eyes missing from the table due to lack of 4-week follow-up, including death or deviation. Of these eyes, 5 study eyes and 4 fellow eyes were missing due to death. Eleven additional enrolled fellow eyes missing due to lack of need for initial injection.
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=13 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=23 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=11 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Number of Study Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Severe ROP: Initial Treatment Failure
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Study Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Severe ROP: Early Reactivation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Study Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Persistent Avascular Retina
|
3 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
3 Participants
|
2 Participants
|
|
Number of Study Eyes Requiring Additional Treatment/s for ROP
No Additional Treatment
|
13 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
|
Number of Study Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Severe ROP: Late Reactivation
|
5 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 12-month corrected age12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=12 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=11 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Any Adverse Events or Complications Since the 4-week Exam
|
4 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
9 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12-month corrected agePopulation: 8 Infants died before exam, exam not completed for 5 participants, and 16 patients were lost to follow up and did not complete.
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=6 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=13 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=8 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=15 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=10 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=13 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Visual Fixation Status at 12 Months
Central Fixation in One Eye
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Visual Fixation Status at 12 Months
Central Fixation in Both Eyes
|
16 Participants
|
6 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
13 Participants
|
|
Visual Fixation Status at 12 Months
No Central Fixation in either eye
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 12-month corrected ageAdverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method 12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=12 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=11 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Infants for Whom at Least One Event Was Reported
|
5 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
11 Participants
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 12-month corrected ageAdverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method 12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=12 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=11 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Proportion of Infants With an Adverse Event Thought by Investigator to be Related to Study Drug
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 12-month corrected ageAdverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. For each dosage level, an estimate and 95% confidence interval of the proportions will be obtained using the exact binomial method.
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=12 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=11 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Count of Infants for Whom at Least One Serious Adverse Event Was Reported
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Enrollment to 12-month corrected ageAdverse events reported at any time during the study will be tabulated for all enrolled infants and coded using the MedRA system. 12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=12 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=11 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Number of Infant Deaths
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24-month corrected ageA subset of infants enrolled in ROP1 will have extended follow up consisting of one additional office exam with developmental testing. This testing will provide a cross-sectional evaluation of visual acuity, refractive error, and development at the adjusted age 24-month visit. 24-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 24 months.
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=9 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=12 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=24 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=11 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=16 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Number of Infants With 24-Month Extended Follow Up Exam
|
15 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
12 Participants
|
6 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12-month corrected agePopulation: Eyes, Seven enrolled study eyes and 11 enrolled fellow eyes missing from the table due to lack of 4-week follow-up, including death or deviation. Of these eyes, 5 study eyes and 4 fellow eyes were missing due to death. Eleven additional enrolled fellow eyes missing due to lack of need for initial injection.
12-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 12 months
Outcome measures
| Measure |
Bevacizumab (0.125 mg)
n=21 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625)
n=6 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=10 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=8 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=11 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=18 Participants
Dosage of injected Bevacizumab to be studied
|
Bevacizumab
n=10 Participants
Dosage if injected Bevacizumab to be studied
Bevacizumab: Varying dosages in 10µl
|
Bevacizumab (0.0125 mg)
n=14 Participants
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
No Additional Treatment
|
11 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
|
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Severe ROP: Initial Treatment Failure
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Severe ROP: Early Reactivation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Severe ROP: Late Reactivation
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Fellow Eyes Requiring Additional Treatment/s for ROP
Additional Treatment Needed : Persistent Avascular Retina
|
2 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Bevacizumab (0.25 mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Bevacizumab (0.125 mg)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Bevacizumab (0.0625 mg)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths
Bevacizumab (0.031 mg)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 2 deaths
Bevacizumab (0.016 mg)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Bevacizumab (0.008 mg)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Bevacizumab (0.004 mg)
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Bevacizumab (0.002 mg)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Bevacizumab (0.25 mg)
n=11 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.125 mg)
n=16 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625 mg)
n=24 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=10 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=14 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=9 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=12 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.002 mg)
n=24 participants at risk
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Small Intestine Perforation
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
11.1%
1/9 • Number of events 1 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
8.3%
2/24 • Number of events 2 • 1 Year
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
12.5%
3/24 • Number of events 3 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 2 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
8.3%
2/24 • Number of events 6 • 1 Year
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea Neonatal
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Blood Potassium increased
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.00%
0/11 • 1 Year
|
18.8%
3/16 • Number of events 3 • 1 Year
|
12.5%
3/24 • Number of events 3 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Disease
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Infections and infestations
Endocarditis
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
11.1%
1/9 • Number of events 1 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Feeding Intolerance
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal tube insertion
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Gastrostomy
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Hepatic Failure
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Blood and lymphatic system disorders
Hypoxia
|
9.1%
1/11 • Number of events 1 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoea
|
0.00%
0/11 • 1 Year
|
12.5%
2/16 • Number of events 2 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Infections and infestations
Infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
General disorders
Influenza
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
7.1%
1/14 • Number of events 1 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Penumonia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Penumonia Aspiration
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Pulmonary Hypertension
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Pyloric stenosis
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
33.3%
4/12 • Number of events 5 • 1 Year
|
8.3%
2/24 • Number of events 3 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
8.3%
2/24 • Number of events 2 • 1 Year
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 2 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Retinal neovascularisation
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 2 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Nervous system disorders
Seizure
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Infections and infestations
Septic Shock
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
Other adverse events
| Measure |
Bevacizumab (0.25 mg)
n=11 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.125 mg)
n=16 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.0625 mg)
n=24 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.031 mg)
n=10 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.016 mg)
n=14 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.008 mg)
n=9 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.004 mg)
n=12 participants at risk
Dosage of injected Bevacizumab to be studied
|
Bevacizumab (0.002 mg)
n=24 participants at risk
Dosage of injected Bevacizumab to be studied
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Any Adverse Event
|
36.4%
4/11 • 1 Year
|
18.8%
3/16 • 1 Year
|
16.7%
4/24 • 1 Year
|
10.0%
1/10 • 1 Year
|
28.6%
4/14 • 1 Year
|
11.1%
1/9 • 1 Year
|
41.7%
5/12 • 1 Year
|
37.5%
9/24 • 1 Year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Bacterameia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Candida infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Cataract
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Cataract cortical
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
7.1%
1/14 • Number of events 1 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Cataract operation
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Cholangitis
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Nervous system disorders
Clonus
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Cardiac disorders
Congenital coronary artery malformation
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
8.3%
2/24 • Number of events 4 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 2 • 1 Year
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 2 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Eye disorders
Corneal Disorder
|
9.1%
1/11 • Number of events 1 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
8.3%
2/24 • Number of events 3 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Eye Discharge
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 2 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Feeding Intolerance
|
18.2%
2/11 • Number of events 2 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Fungal Skin Infection
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Gastrointestinal tube insertion
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/11 • 1 Year
|
12.5%
2/16 • Number of events 2 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Haemangioma of Skin
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
General disorders
Hernia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
7.1%
1/14 • Number of events 1 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Reproductive system and breast disorders
Hydrocele
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
7.1%
1/14 • Number of events 1 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Hypocalcaemia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
General disorders
Hypoxia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
General disorders
Infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
Intestinal Perforation
|
9.1%
1/11 • Number of events 1 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Iris Adhesions
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
7.1%
1/14 • Number of events 1 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Laryngomalacia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Metabolic Alkalosis
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Penumonia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
9.1%
1/11 • Number of events 1 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Retinal Detachment
|
18.2%
2/11 • Number of events 2 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
7.1%
1/14 • Number of events 1 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Eye disorders
Retinal Disorder
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Eye disorders
Retinal Haemorrhage
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
14.3%
2/14 • Number of events 2 • 1 Year
|
11.1%
1/9 • Number of events 2 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Eye disorders
Retinal Vein Occlusion
|
9.1%
1/11 • Number of events 2 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Eye disorders
Retinopathy
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 2 • 1 Year
|
|
Nervous system disorders
Seizure
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
11.1%
1/9 • Number of events 1 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Skin and subcutaneous tissue disorders
Thermal Burn
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
8.3%
1/12 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
11.1%
1/9 • Number of events 1 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
7.1%
1/14 • Number of events 1 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
10.0%
1/10 • Number of events 1 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
|
Renal and urinary disorders
Urinary Tract infection
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
4.2%
1/24 • Number of events 1 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/11 • 1 Year
|
0.00%
0/16 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
4.2%
1/24 • Number of events 2 • 1 Year
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 2 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/11 • 1 Year
|
6.2%
1/16 • Number of events 1 • 1 Year
|
0.00%
0/24 • 1 Year
|
0.00%
0/10 • 1 Year
|
0.00%
0/14 • 1 Year
|
0.00%
0/9 • 1 Year
|
0.00%
0/12 • 1 Year
|
0.00%
0/24 • 1 Year
|
Additional Information
Raymond Kraker, PEDIG Coordinating Center Director
Jaeb Center for Health Research
Phone: 8139758690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place